Phase III study of nilotinib versus best supportive care with or without a TKI in patients with gastrointestinal stromal tumors resistant to or intolerant of imatinib and sunitinib
Identifieur interne : 005A05 ( Main/Exploration ); précédent : 005A04; suivant : 005A06Phase III study of nilotinib versus best supportive care with or without a TKI in patients with gastrointestinal stromal tumors resistant to or intolerant of imatinib and sunitinib
Auteurs : P. Reichardt [Allemagne] ; J.-Y. Blay [France] ; H. Gelderblom [Pays-Bas] ; M. Schlemmer [Allemagne] ; G. D. Demetri [États-Unis] ; B. Bui-Nguyen [France] ; G. A. Mcarthur [Australie] ; S. Yazji [États-Unis] ; Y. Hsu [États-Unis] ; I. Galetic [Suisse] ; P. Rutkowski [Pologne]Source :
- Annals of oncology [ 0923-7534 ] ; 2012.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
Background: This phase III open-label trial investigated the efficacy of nilotinib in patients with advanced gastrointestinal stromal tumors following prior imatinib and sunitinib failure. Patients and methods: Patients were randomized 2: 1 to nilotinib 400 mg b.i.d. or best supportive care (BSC; BSC without tyrosine kinase inhibitor, BSC + imatinib, or BSC + sunitinib). Primary efficacy end point was progression-free survival (PFS) based on blinded central radiology review (CRR). Patients progressing on BSC could cross over to nilotinib. Results: Two hundred and forty-eight patients enrolled. Median PFS was similar between arms (nilotinib 109 days, BSC 111 days; P = 0.56). Local investigator-based intent-to-treat (ITT) analysis showed a significantly longer median PFS with nilotinib (119 versus 70 days; P = 0.0007). A trend in longer median overall survival (OS) was noted with nilotinib (332 versus 280 days; P = 0.29). Post hoc subset analyses in patients with progression and only one prior regimen each of imatinib and sunitinib revealed a significant difference in median OS of >4 months in favor of nilotinib (405 versus 280 days; P = 0.02). Nilotinib was well tolerated. Conclusion: In the ITT analysis, no significant difference in PFS was observed between treatment arms based on CRR. In the post hoc subset analyses, nilotinib provided significantly longer median OS.
Affiliations:
- Allemagne, Australie, France, Pays-Bas, Pologne, Suisse, États-Unis
- Aquitaine, Auvergne-Rhône-Alpes, Bavière, District de Haute-Bavière, Hollande-Méridionale, Massachusetts, Nouvelle-Aquitaine, Rhône-Alpes, Victoria (État)
- Bordeaux, Boston, Leyde, Lyon, Melbourne, Munich
Links toward previous steps (curation, corpus...)
- to stream PascalFrancis, to step Corpus: 001235
- to stream PascalFrancis, to step Curation: 004C82
- to stream PascalFrancis, to step Checkpoint: 000E64
- to stream Main, to step Merge: 005C99
- to stream Main, to step Curation: 005A05
Le document en format XML
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<author><name sortKey="Mcarthur, G A" sort="Mcarthur, G A" uniqKey="Mcarthur G" first="G. A." last="Mcarthur">G. A. Mcarthur</name>
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<author><name sortKey="Yazji, S" sort="Yazji, S" uniqKey="Yazji S" first="S." last="Yazji">S. Yazji</name>
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<author><name sortKey="Galetic, I" sort="Galetic, I" uniqKey="Galetic I" first="I." last="Galetic">I. Galetic</name>
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<author><name sortKey="Rutkowski, P" sort="Rutkowski, P" uniqKey="Rutkowski P" first="P." last="Rutkowski">P. Rutkowski</name>
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<s2>Warsaw</s2>
<s3>POL</s3>
<sZ>11 aut.</sZ>
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<author><name sortKey="Reichardt, P" sort="Reichardt, P" uniqKey="Reichardt P" first="P." last="Reichardt">P. Reichardt</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>HELIOS Klinikum Bad Saarow, Sarkomzentrum Berlin-Brandenburg</s1>
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<author><name sortKey="Blay, J Y" sort="Blay, J Y" uniqKey="Blay J" first="J.-Y." last="Blay">J.-Y. Blay</name>
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<author><name sortKey="Gelderblom, H" sort="Gelderblom, H" uniqKey="Gelderblom H" first="H." last="Gelderblom">H. Gelderblom</name>
<affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Department of Clinical Oncology, Leiden University Medical Center</s1>
<s2>Leiden</s2>
<s3>NLD</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
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<region nuts="2" type="province">Hollande-Méridionale</region>
</placeName>
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<author><name sortKey="Schlemmer, M" sort="Schlemmer, M" uniqKey="Schlemmer M" first="M." last="Schlemmer">M. Schlemmer</name>
<affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Internal Medicine III, University Hospitals Grosshadern, Ludwig Maximilians University Munich</s1>
<s2>Munich</s2>
<s3>DEU</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="1">Bavière</region>
<region type="district" nuts="2">District de Haute-Bavière</region>
<settlement type="city">Munich</settlement>
</placeName>
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<author><name sortKey="Demetri, G D" sort="Demetri, G D" uniqKey="Demetri G" first="G. D." last="Demetri">G. D. Demetri</name>
<affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Center for Sarcoma and Bone Oncology, Ludwig Center at Dana-Farber/Harvard Cancer Center, Dana-Farber Cancer Institute</s1>
<s2>Boston</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><settlement type="city">Boston</settlement>
<region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bui Nguyen, B" sort="Bui Nguyen, B" uniqKey="Bui Nguyen B" first="B." last="Bui-Nguyen">B. Bui-Nguyen</name>
<affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Institut Bergonié</s1>
<s2>Bordeaux</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Nouvelle-Aquitaine</region>
<region type="old region">Aquitaine</region>
<settlement type="city">Bordeaux</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mcarthur, G A" sort="Mcarthur, G A" uniqKey="Mcarthur G" first="G. A." last="Mcarthur">G. A. Mcarthur</name>
<affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Division of Cancer Medicine, Peter MacCallum Cancer Center</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Yazji, S" sort="Yazji, S" uniqKey="Yazji S" first="S." last="Yazji">S. Yazji</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Novartis Pharmaceuticals Corporation</s1>
<s2>Florham Park</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Novartis Pharmaceuticals Corporation</wicri:noRegion>
</affiliation>
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<author><name sortKey="Hsu, Y" sort="Hsu, Y" uniqKey="Hsu Y" first="Y." last="Hsu">Y. Hsu</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Novartis Pharmaceuticals Corporation</s1>
<s2>Florham Park</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Novartis Pharmaceuticals Corporation</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Galetic, I" sort="Galetic, I" uniqKey="Galetic I" first="I." last="Galetic">I. Galetic</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Novartis Pharma AG</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
<wicri:noRegion>Novartis Pharma AG</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Rutkowski, P" sort="Rutkowski, P" uniqKey="Rutkowski P" first="P." last="Rutkowski">P. Rutkowski</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Soft Tissue/Bone Sarcoma and Melanoma, M. Sklodowska-Curie Memorial Cancer Center and Institute of Oncology</s1>
<s2>Warsaw</s2>
<s3>POL</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Pologne</country>
<wicri:noRegion>Warsaw</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Annals of oncology</title>
<title level="j" type="abbreviated">Ann. oncol.</title>
<idno type="ISSN">0923-7534</idno>
<imprint><date when="2012">2012</date>
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</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Annals of oncology</title>
<title level="j" type="abbreviated">Ann. oncol.</title>
<idno type="ISSN">0923-7534</idno>
</seriesStmt>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiangiogenic agent</term>
<term>Antineoplastic agent</term>
<term>Comparative study</term>
<term>Enzyme inhibitor</term>
<term>Gastrointestinal stromal tumor</term>
<term>Human</term>
<term>Imatinib</term>
<term>Nilotinib</term>
<term>Patient</term>
<term>Phase III trial</term>
<term>Protein-tyrosine kinase</term>
<term>Resistance</term>
<term>Sunitinib</term>
<term>Supportive care</term>
<term>Treatment</term>
<term>Tyrosine kinase inhibitor</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Homme</term>
<term>Essai clinique phase III</term>
<term>Traitement</term>
<term>Nilotinib</term>
<term>Etude comparative</term>
<term>Soin de support</term>
<term>Malade</term>
<term>Tumeur stromale gastro-intestinale</term>
<term>Résistance</term>
<term>Imatinib</term>
<term>Sunitinib</term>
<term>Inhibiteur enzyme</term>
<term>Protein-tyrosine kinase</term>
<term>Inhibiteur de la tyrosine kinase</term>
<term>Anticancéreux</term>
<term>Antiangiogénique</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
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<front><div type="abstract" xml:lang="en">Background: This phase III open-label trial investigated the efficacy of nilotinib in patients with advanced gastrointestinal stromal tumors following prior imatinib and sunitinib failure. Patients and methods: Patients were randomized 2: 1 to nilotinib 400 mg b.i.d. or best supportive care (BSC; BSC without tyrosine kinase inhibitor, BSC + imatinib, or BSC + sunitinib). Primary efficacy end point was progression-free survival (PFS) based on blinded central radiology review (CRR). Patients progressing on BSC could cross over to nilotinib. Results: Two hundred and forty-eight patients enrolled. Median PFS was similar between arms (nilotinib 109 days, BSC 111 days; P = 0.56). Local investigator-based intent-to-treat (ITT) analysis showed a significantly longer median PFS with nilotinib (119 versus 70 days; P = 0.0007). A trend in longer median overall survival (OS) was noted with nilotinib (332 versus 280 days; P = 0.29). Post hoc subset analyses in patients with progression and only one prior regimen each of imatinib and sunitinib revealed a significant difference in median OS of >4 months in favor of nilotinib (405 versus 280 days; P = 0.02). Nilotinib was well tolerated. Conclusion: In the ITT analysis, no significant difference in PFS was observed between treatment arms based on CRR. In the post hoc subset analyses, nilotinib provided significantly longer median OS.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>France</li>
<li>Pays-Bas</li>
<li>Pologne</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region><li>Aquitaine</li>
<li>Auvergne-Rhône-Alpes</li>
<li>Bavière</li>
<li>District de Haute-Bavière</li>
<li>Hollande-Méridionale</li>
<li>Massachusetts</li>
<li>Nouvelle-Aquitaine</li>
<li>Rhône-Alpes</li>
<li>Victoria (État)</li>
</region>
<settlement><li>Bordeaux</li>
<li>Boston</li>
<li>Leyde</li>
<li>Lyon</li>
<li>Melbourne</li>
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<tree><country name="Allemagne"><noRegion><name sortKey="Reichardt, P" sort="Reichardt, P" uniqKey="Reichardt P" first="P." last="Reichardt">P. Reichardt</name>
</noRegion>
<name sortKey="Schlemmer, M" sort="Schlemmer, M" uniqKey="Schlemmer M" first="M." last="Schlemmer">M. Schlemmer</name>
</country>
<country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Blay, J Y" sort="Blay, J Y" uniqKey="Blay J" first="J.-Y." last="Blay">J.-Y. Blay</name>
</region>
<name sortKey="Bui Nguyen, B" sort="Bui Nguyen, B" uniqKey="Bui Nguyen B" first="B." last="Bui-Nguyen">B. Bui-Nguyen</name>
</country>
<country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Gelderblom, H" sort="Gelderblom, H" uniqKey="Gelderblom H" first="H." last="Gelderblom">H. Gelderblom</name>
</region>
</country>
<country name="États-Unis"><region name="Massachusetts"><name sortKey="Demetri, G D" sort="Demetri, G D" uniqKey="Demetri G" first="G. D." last="Demetri">G. D. Demetri</name>
</region>
<name sortKey="Hsu, Y" sort="Hsu, Y" uniqKey="Hsu Y" first="Y." last="Hsu">Y. Hsu</name>
<name sortKey="Yazji, S" sort="Yazji, S" uniqKey="Yazji S" first="S." last="Yazji">S. Yazji</name>
</country>
<country name="Australie"><region name="Victoria (État)"><name sortKey="Mcarthur, G A" sort="Mcarthur, G A" uniqKey="Mcarthur G" first="G. A." last="Mcarthur">G. A. Mcarthur</name>
</region>
</country>
<country name="Suisse"><noRegion><name sortKey="Galetic, I" sort="Galetic, I" uniqKey="Galetic I" first="I." last="Galetic">I. Galetic</name>
</noRegion>
</country>
<country name="Pologne"><noRegion><name sortKey="Rutkowski, P" sort="Rutkowski, P" uniqKey="Rutkowski P" first="P." last="Rutkowski">P. Rutkowski</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>
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